Counterfeit medicines are prevalent across the globe. From proprietary medicines to generic drugs, counterfeiters are not only targeting lifestyle drugs such as Viagra and Cialis, but also expensive treatments for life-threatening conditions such as cancer. This year saw the appearance of counterfeit Avastin, which affected 19 medical practices in the United States, demonstrating that even countries with stringent regulatory and enforcement systems are not exempt from the escalating problem of counterfeits (1). In this digital age, the Internet provides an easy channel for counterfeiters to dispense their fakes. Purchasing medicines online with just a click of the mouse is becoming increasingly prevalent because of the convenience it offers, and according to the World Health Organization (WHO), constitutes more than 50% of counterfeit cases (2). In July 2011, the European Commission published the Falsified Medicines Directive (FMD) 2011/62/EU in an effort to better protect patients and consumers. The new directive, which aims to prevent falsified medicines from entering the legal supply chain and reaching patients, will come into effect in January 2013. Meanwhile, FDA's Safety and Innovation Act (FDASIA), enforced in July 2012, has made provisions to ensure the safety of drugs, for example by implementing new counterfeiting penalties, including one for trafficking fake medicines.

To examine the progress made to date in the war against counterfeits, PharmTech spoke with Lynne Byers, vice-president of quality at GlaxoSmithKline, and Brian Johnson, senior director of supply-chain security at Pfizer. Both are representatives and members of Rx–360, an international pharmaceutical supply chain consortium developed by volunteers from the pharmaceutical and biotech industry, with a mission to protect patient safety by enhancing the security of the pharmaceutical supply chain to assure the quality and authenticity of products and materials moving through the supply chain.

Lynne Byers

PharmTech: How successful have regulators and the pharmaceutical industry been in the battle against counterfeits?

Johnson: We have made great progress as an industry in battling counterfeit medicines and other supply-chain security breaches; however, there is still much more to do. Some examples of positive progress from a legislative perspective include the passing of the FMD in Europe and FDASIA in the US. Operation Pangea is an example of collaborative enforcement efforts, where an international law enforcement campaign involving 100 countries succeeded in shutting down more than 18,000 rogue online pharmacies. Rx–360 has also done some great work in the supply-chain security space, with several white papers that will help prevent, detect, and respond to counterfeiting and other supply-chain security threats. There are many other examples and they all contribute to our fight in different ways. Nevertheless, even with these success stories, we still see examples of global supply-chain security breaches in the news every day. We must remain vigilant.